Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART. (ROaR+)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Andrew Carr, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier:
NCT01258439
First received: December 9, 2010
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

This is a research study into the effects of three drugs used to treat HIV infection. Some drugs used to treat HIV have been associated with changes in blood fats such as cholesterol that could be harmful over the long-term, because these blood fat changes have been associated with a small, increased risk of heart disease and stroke in some studies of adults with HIV. Now that HIV can be controlled for long periods in most patients, and because heart disease is one of the biggest causes of illness and death in the general population, it is important to develop new HIV treatments that control HIV effectively but do not cause abnormal blood fats.

Hypothesis: That Raltegravir will result in less post-prandial lipid disturbances than ritonavir-boosted darunavir.


Condition Intervention Phase
HIV
Cardiovascular Disease
Drug: raltegravir plus truvada
Drug: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir-boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)-Naive Adults or Adults Recommencing ART.

Resource links provided by NLM:


Further study details as provided by St Vincent's Hospital, Sydney:

Primary Outcome Measures:
  • To compare the effects of ritonavir plus darunavir daily to raltegravir twice daily on post prandial lipid responses over 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Fasting samples will be taken for total cholesterol, LDL and HDL cholesterol, and triglycerides. Repeat lipid samples will be collected before a high fat meal is consumed. After the meal is completed , blood will be collected at 1, 2, 3, and 4 hours at baseline, week 4 and week 24 visits.


Secondary Outcome Measures:
  • safety [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Safety parameters will be assessed by measurement of urea and electrolytes, LFTs, urine protein to creatinine ratio

  • Other metabolic parameters [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Fasting metabolic parameters will be assessed. Study staff and participants will be blinded to the results fo these tests until completion of the study or parameters become sginificantly abnormal

  • Arterial stiffness [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1.Raltegravir plus truvada
Raltegravir 400mg twice daily plus truvada 300mg/200mg once daily for 24 weeks
Drug: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)
Darunavir two 400mg tablets with one ritonavir 100mg capsule once daily plus Tenofovir/emtricitabine (Truvada) one 300mg/200mg tablet once daily with food for 24 weeks
Other Names:
  • Prezista
  • Norvir
  • Tenofovir/emtricitabine
Active Comparator: 2. ritonavir boosted darunavir plus truvada
Darunavir 800mg with ritonavir 100mg plus truvada 300mg/200mg once daily for 24 weeks
Drug: raltegravir plus truvada
raltegravir 400 mg tablet with truvada 300/200 mg tablet for 24 weeks
Other Names:
  • tenofovir disoproxil fumarate
  • Isentress

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of signed, informed consent
  • Age >18 years
  • HIV infection documented by HIV antibody test and Western Blot prior to study entry
  • No previous ART OR no ART for 6 months prior to randomisation
  • CD4+ count of <500 cells/mm or viral load >10,000 copies/ml within 60 days prior to randomisation
  • No genotypic resistance to Raltegravir, Tenofovir/emtricitabine, Darunavir, Ritonavir
  • Body mass index less than 30kg/m2

Exclusion Criteria:

  • Primary HIV infection within the last 6 months
  • Active infection or opportunistic illness within the previous 30 days
  • Use of any medication contra-indicated with ritonavir-boosted darunavir or raltegravir
  • Use of lipid-lowering therapy
  • Diabetes mellitus (fasting glucose >7.0mml/l or a prior diagnosis of diabetes)
  • Use of oral prednisolone > 7.5mg daily or equivalent
  • pregnancy or Breast feeding
  • proven hypersensitivity to one or more components of the study meal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258439

Locations
Australia, New South Wales
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010
St Vincent Hospital, Clinical Research Program
Sydney, New South Wales, Australia, 2010
Sponsors and Collaborators
St Vincent's Hospital, Sydney
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Andrew D Carr, Professor St Vincent's Hospital, Sydney, Australia
  More Information

No publications provided

Responsible Party: Andrew Carr, Head, Clinical Research Program, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier: NCT01258439     History of Changes
Other Study ID Numbers: ROaR+
Study First Received: December 9, 2010
Last Updated: April 15, 2014
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by St Vincent's Hospital, Sydney:
HIV
cardiovascular disease
post prandial lipids
ritonavir
darunavir
raltegravir
arterial stiffness
tonometry

Additional relevant MeSH terms:
Cardiovascular Diseases
Darunavir
Emtricitabine
Ritonavir
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014